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Principal Biostatistician
Job Summary
A company is looking for a FSP Principal Biostatistician for Early Phase Clinical Development (PK).
Key Responsibilities
- Collaborate with project teams to establish timelines and provide statistical input to study protocols
- Write and review statistical sections of clinical trial protocols, including analysis plans and randomizations
- Perform inferential analyses using SAS and/or R, and interpret study results for accuracy
Required Qualifications
- PhD in Statistics, Biostatistics, or related field with 3+ years of industry experience, or MS with 5+ years of experience
- 2+ years of experience in statistical analysis of non-compartmental PK endpoints
- Understanding of ICH GCP and regulatory guidance for clinical pharmacology studies
- Experience with CDISC standards including SDTM, ADaM, and CDASH
- Proficiency in SAS for data analysis and validation
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COMPLETE JOB DESCRIPTION
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